MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSYFEMORAL STEM BEADED FULLCOAT 12/14 NECK TAPER STD.; PROSTHESIS, HIP

Model Number N/A

Device Problem Delivered as Unsterile Product (1421)

Patient Problems Unspecified Infection (1930); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that one patient who had received one of the recalled devices, due to packaging sterility, is now experiencing an infection.No additional patient consequences were reported.

Manufacturer Narrative

The follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was further reported that the patient is having difficulty walking and has to use crutches to ambulate.

Manufacturer Narrative

Concomitant medical products: bioloxâ® delta, ceramic femoral head cat#: 00877503202, lot# 2857154; shell porous with cluster holes cat#: 00620006822, lot# 60798368; liner 10 degree elevated rim cat#: 00631006832, lot# 62788130; bone scr 6.5x20 self-tap cat#: 00625006520, lot# 63176671; bone scr 6.5x20 self-tap cat#: 00110100200, lot# 63160848; dough type radiopaque bone cement cat#: 00110100200, lot# 63137839.The follow-up report is being submitted to relay additional information.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

The reported event has not been confirmed.No device or photos were received; therefore the condition of the device is unknown.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Please see associated mdrs: 0002648920 - 2018 - 00400; 0001822565 - 2018 - 02586.

• Brand Name: VERSYFEMORAL STEM BEADED FULLCOAT 12/14 NECK TAPER STD.
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7011241
• MDR Text Key: 91381803
• Report Number: 0001822565-2017-07632
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: PK953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00784301506
• Device Lot Number: 62659597
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 105